Kornimate/medical-research-clean huggingface dataset:
cognitive training to enhance va work program outcomes

Conditions: Mental Illness; Schizophrenia; Depression; PTSD; Bipolar Disorder

Summary: the purpose of this study is to determine whether augmenting work services with cognitive remediation can improve vocational outcomes for psychiatrically disabled participants in va work services.

background: our previous rr\&d funded study demonstrated significantly better vocational outcomes for people with schizophrenia when cognitive training supplemented their participation in incentive therapy. we have found in a subsequent nimh funded study involving cognitive training and supported employment that competitive employment outcomes were better for those who received cognitive training. moreover, we found that patients with the poorest community function at intake were very unlikely to obtain competitive employment unless they received the cognitive training. the current study will test the effectiveness of cognitive training by extending it to a broader range of va patients with psychotic disorders participating in all types of va work services currently available, including incentive therapy, compensated work therapy, and supported employment. we plan to offer it to any patient with a psychotic disorder who is unlikely to obtain competitive employment without additional services. we will also compare two types of cognitive training to determine whether cognitive game software works as well narrowly focused cognitive exercises. design and method: this is a randomized clinical trial in which 80 va patients referred for va work services and who meet criteria for psychotic disorder and impaired community function will be randomized to one of two types of cognitive training. there will be two conditions with approximately 40 subjects per condition. intake procedures will include psychosocial, neuropsychological, and psychiatric assessments. these assessments will be repeated at 6-months and 12 month follow-up. cognitive training will consist of computer-based cognitive exercises of attention, memory and problem-solving and a weekly group that focuses on improving work behaviors. one of the computer-based systems employs engaging cognitive game software and the other uses specially designed exercises that narrowly focus on discrete cognitive processes. work services will be provided as usual to both conditions. primary endpoints are measures of productive activity including obtaining competitive employment, total hours worked, and money earned. secondary endpoints include neuropsychological, quality of life and health status changes. the study will be for three years.

Eligibility criteria:
inclusion criteria: * participant in va work services * chronic and disabling psychiatric illness exclusion criteria: * neurological disease that may affect cognition * primary substance abuse * developmental disability

Keywords: neuropsychology cognitive remediation vocational rehabilitation schizophrenia severe and persistent mental illness chronic and disabling mental illness
cbt for problematic impulsive behaviours in bipolar disorder: a case series / cbt-pib

Conditions: Impulsivity; Bipolar Disorder; Hypomania; Bipolar I Disorder; Bipolar II Disorder; Bipolar Affective Disorder; Impulsive Behavior

Summary: the goal of this case series is to explore whether a talking therapy, specifically cognitive behavioural therapy (cbt) is acceptable and feasible in the management of mood-driven impulsive behaviours in people with bipolar disorder (bd). the main questions it aims to answer are: * whether cbt is a feasible intervention for participants with bd who report mood-driven, problematic impulsive behaviours. * whether cbt for mood-driven, problematic impulsive behaviours (cbt-pib) is acceptable to service users with bd and therapists. * whether clinical outcomes are consistent with the potential for this novel intervention to offer clinical benefit to participants with bd. the study also hopes to: * conduct a preliminary examination of the safety of cbt-pib and the research procedures. * gather information on the potential mechanisms of action of cbt-pib and, * gather information on the types of mood-driven impulsive behaviours individuals with bd may seek support for. participants will: * be offered up to 12 individual sessions of cbt focusing on mood-driven impulsive behaviours. * be asked to complete a battery of self-report measures (5) when they enter the study and at the start and end of treatment. * be asked to track mood and impulsive behaviours by completing a brief set of measures (3) weekly during the two-week baseline phase, the intervention phase and the 2-week post-intervention phase. * be asked to complete a survey on the acceptability of the intervention and * be invited to an optional semi-structured interview on their research experience.


Eligibility criteria:
inclusion criteria: * meeting diagnostic criteria for bipolar i or ii disorder (scid-5- structured clinical interview for depression ) * able to identify at least one impulsive, problematic behaviour to target during the intervention; * participants will require working knowledge of written and spoken english, sufficient to be able to make use of therapy and to be able complete research assessments without the need of a translator. exclusion criteria: * major depressive episode (identified through scid-dsm-5); * current experience of mania; * current/past learning disability (iq of less than 70 with impairment of social and adaptive functioning) * organic brain change or substance dependence (drugs and alcohol) that would compromise ability to use therapy; * current marked risk to self (i.e. self-harm or suicide) that we deem could not be appropriately managed in by the therapy site; * currently lacking capacity to give informed consent; * currently receiving other psychosocial therapy for impulsivity or bipolar disorder; * current engagement in another psychological intervention addressing bipolar disorder or impulsivity; * presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, post-traumatic stress disorder, psychosis).
study of vardenafil in patients suffering from erectile dysfunction and metabolic syndrome

Conditions: Erectile Dysfunction; Metabolic Syndrome

Summary: this is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on erectile dysfunction (ed), tolerability and safety in men with ed and metabolic syndrome. this study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg prn (pro re nata)


Eligibility criteria:
inclusion criteria: * stable heterosexual relationship * history of erectile dysfunction for at least 6 months * iief- ef domain entry score (at visit 2): \>21 points * documented metabolic syndrome according to the idf (international diabetes foundation) * subjects motivated for erectile dysfunction treatment * documented, dated, written informed consent exclusion criteria: * any underlying cardiovascular condition * history of myocardial infarction * uncontrolled atrial fibrillation * resting hypotension * postural hypotension within 6 months of visit 1 * history of congenital qt prolongation * bleeding disorder * history of prostatectomy because of prostate cancer * hereditary degenerative retinal disorders * history of loss of vision because of naion (non-arteritic anterior ischemic optic neuropathy) * 29 additional exclusion criteria

Keywords: vardenafil erectile dysfunction double-blind study
evaluation of the use of metal stents as part of the treatment of benign biliary strictures

Conditions: Benign Biliary Strictures

Summary: the purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.

in patients with benign biliary strictures, the use of fully covered self-expandable metal stents (sems) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. this study was performed to evaluate the long -term effectiveness and safety of a new fully covered sems for benign biliary strictures.

Eligibility criteria:
inclusion criteria: 1. subject is 18 years or older 2. subject has benign biliary stricture 3. subject must be able to give informed consent exclusion criteria: 1. any contraindication to endoscopic retrograde cholangiopancreatography (ercp) 2. the subject is unable to give informed consent
the effect of progressive relaxation exercises on premenstrual syndrome symptoms

Conditions: Premenstrual Syndrome

Summary: the aim of this study; to determine the effect of progressive relaxation exercises on premenstrual syndrome symptoms. the study is a randomized controlled trial, and women between the ages of 18-35 who meet the inclusion criteria will be included. participant information form and premenstrual syndrome scale will be used in the research. there are two groups in the study as experimental (n=40) and control (n=40).

institutional permission and ethics committee approval were obtained for the research. the population of the study consisted of 218 women. the sample of the study consisted of 80 women, 40 of which were experimental and 40 control. participants were evaluated according to the www.randomizer.org program and randomization was achieved among the women participating in the study. the research process and the participants in the experimental and control groups will be explained again and the necessary equipment will be provided by the researchers. the "progressive relaxation exercises guide" prepared by the researcher in accordance with the literature will be given to the women in the experimental group (40), taking the opinions and suggestions of eight experts. at the same time, the comprehensibility and applicability of the guide were evaluated by making a pilot application to 10 women before the research. afterwards, all the information in the guide will be explained to the women in the experimental group and training will be given until adequate feedback is received. at the same time, progressive relaxation exercises belonging to the turkish psychological association were given to the women in cd form, and listening to the audio recordings together with the relaxation exercises to be performed in accordance with the guide will be indicated. these exercises will be performed by the women in the experimental group for 25-30 minutes a day, every day for 8 weeks. at the end of 8 weeks, women will be reassessed with pmss. the women in the control group (40) will be told to continue their routine habits regarding pms in parallel with the study group, without any application. at the end of 8 weeks, women in the control group will be re-evaluated with pmss.

Eligibility criteria:
inclusion criteria: * being between 18-35 years old, single marital status, * willingness and volunteering to work, * being able to read and write in turkish and understand what he reads, * applying to the obstetrics and gynecology outpatient clinic for routine control, * getting a score of 110 and above in pmss. exclusion criteria: * the woman has an obstetric or medical health problem that prevents her from doing progressive relaxation exercises, * having a chronic and gynecological health problem, * regular exercise, * there is a change in menstrual characteristics in the last six months.

Keywords: premenstrual syndrome, exercises, women health
comparison of 4.5/6.5f and 7.5/9.5f ureteroscopes in endoscopic ureteral stone treatment

Conditions: Ureteral Stones; Ureteroscopic Lithotripsy

Summary: this study aims to compare the efficacy, success rates, and stone-free rates of endoscopic ureteral stone treatment performed using two different sizes of ureteroscopes. additionally, the psychological stress experienced by the surgeon will be evaluated immediately before and immediately after the procedure using the six-item short-form of the state scale of the spielberger state-trait anxiety inventory (stai). the findings will provide insight into the impact of ureteroscope size on procedural outcomes and surgeon stress levels, contributing to the optimization of ureteroscopic stone treatment.

patients admitted to our clinic with ureteral calculi and scheduled for ureteroscopic lithotripsy will be informed about the procedure, potential complications, and routine protocol by the investigator. patients who consent to the operation will subsequently receive detailed information about the study. those agreeing to participate will provide written informed consent. during the ureteroscopy procedure, standard clinical protocols will be followed. the choice of ureteroscope (4.5-6 fr or 7.5-9.5 fr) will be made by the operating urologist based on the patient's ureteral orifice and ureteral width. the study will not influence the selection of the ureteroscope. intraoperative parameters, including procedure duration, complications, double-j stent placement, failure to access the stone, and basket use, will be recorded by the research team. to assess the impact of ureteroscope size on surgical stress, the operating surgeon's stress levels will be evaluated immediately before and after the procedure using the six-item short-form of the state scale of the spielberger state-trait anxiety inventory (stai). postoperatively, all patients undergoing ureteroscopic lithotripsy will undergo a supine direct abdominal radiograph on postoperative day 1, as per routine clinical practice. stone-free status will be determined based on this radiograph and recorded by the investigator. throughout the study period, no modifications to standard clinical procedures will be made.

Eligibility criteria:
inclusion criteria: * presence of ureteral calculi * use of ho:yag laser in ureteric lithotripsy * patient's acceptance to participate in the study exclusion criteria: * presence of active urinary tract infection * emergency operation of the patient * presence of bilateral ureteral calculi * patient refusal to participate in the study

Keywords: ureteral stone anxiety inventory ureteroscoppic lithotripsy ureteroscop
osteopontin as a biomarker in pancreatitis

Conditions: Pancreatitis

Summary: in the early phase of pancreatits, factors that can give information about the development of severety are still lacking. in this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. the aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.

in the early phase of pancreatits, factors that can give information about the development of severety are still lacking. in this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. the aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis. patients admitted and diagnosed with pancreatitis (according to the atlanta criteria) will have serial testing of se-osteopontin in addiation to rutine blood work. computet tomograpy and chest x-ray are mandatory as is blood culture.

Eligibility criteria:
inclusion criteria: * diagnosis of pancreatitis exclusion criteria: * pregnancy, lactation, unable to understand the study
a single center registry of coronary oct

Conditions: Coronary Artery Disease; Optical Coherence Tomography; Registry

Summary: this registry started january 1,2020 to collect patients who recieve coronary oct imaging in hainan general hospital.all enrolled patients will receive 1 year followed-up.

this registry started january 1,2020.patients \>= 18 years old who recieve coronary oct imaging in hainan general hospital are included in current registry.

Eligibility criteria:
inclusion criteria: * subjects who recieved intracoronary oct imaging during cardiac catheterization are eligible for this registry. exclusion criteria: * none
rollover study to provide continued treatment for participants with b-cell malignancies previously enrolled in studies of parsaclisib (incb050465)

Conditions: B-Cell Malignancies

Summary: this is a phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from incyte-sponsored studies of parsaclisib.

the purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent protocol, and who are unable to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib outside a clinical study. participants will continue on the same dose and schedule as the ones being administered in the incyte-sponsored parent protocol at the time of the rollover. the study will collect and assess safety information with regards to aes.

Eligibility criteria:
inclusion criteria: * currently enrolled and receiving treatment in an incyte-sponsored clinical study of parsaclisib. * currently tolerating treatment in the parent protocol. * currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib as determined by the investigator. * has at least stable disease, as determined by the investigator. * has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. * willingness and ability to comply with scheduled visits, treatment plans, including pjp prophylaxis, and any other study procedures indicated in this protocol. * willingness to avoid pregnancy or fathering children * ability to comprehend and willingness to sign an icf exclusion criteria: * has been permanently discontinued from study treatment in the parent protocol for any reason. * able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study. * participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the protocol. * pregnant or breastfeeding women.

Keywords: non-hodgkin lymphoma phosphatidylinositol 3-kinase myeloproliferative neoplasm
rapid breath-hold quantitative macromolecular proton fraction imaging for liver fibrosis

Conditions: Liver Fibrosis

Summary: chronic liver disease is a major health problem worldwide. liver fibrosis is a key feature in most chronic liver diseases. when identified early, liver fibrosis may be reversible. currently, liver biopsy is the gold standard for the diagnosis of liver fibrosis. liver biopsy; however, is invasive. non-invasive diagnostic tools are increasingly used in clinical practice. however, the existing noninvasive methods still have significant limitations to detect early-stage liver fibrosis. liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver. the macromolecular proton fraction (mpf) is an mri parameter which characterizes the magnetization transfer (mt) effect in tissues. quantitative mpf imaging is non-invasive and can be used to measure collagen deposition in the liver due to the strong mt effect of collagen. it has been reported mpf quantification can be used for diagnosis of early-stage liver fibrosis. however, the existing approaches require b1, b0, and t1 map in addition to the imaging data for mpf quantification, which makes it challenging to adopt them for routine clinical use. the investigators propose a fast and robust mpf quantification approach. in contrast to the existing methods which rely on saturation radiofrequency pulses for mpf quantification, our approach is based on spin-lock radiofrequency pulses which have minimum rabi oscillations. the whole imaging data can be acquired within a breath-hold less than 8 seconds. our approach only needs a b1 map in addition to the imaging data for mpf quantification. the preliminary clinical studies on 3.0t mri show the measurement using our approach is specific to collagen content and can be used to detect early-stage liver fibrosis. to further confirm the clinical value of the proposed approach, the investigators will investigate the relationship of the collagen content measured using the proposed non-invasive imaging approach and those measured based on morphometry analysis of histology, and determine the diagnostic value of the proposed method for detection of early stage liver fibrosis in a large cohort. the investigators will also perform comparative studies of the proposed method and the state-of-the-art quantitative mpf imaging technique. this project will provide a diagnostic technology for early detection of liver fibrosis. the proposed mri technology also has potential to be used for other clinical purposes.


Eligibility criteria:
inclusion criteria: 1. patient group * patients with histology-proven liver fibrosis, including those with liver fibrosis stage f0, early-stage liver fibrosis (f1-2), and late stage. liver fibrosis(f3-4). * patient aged 18 years old and above. 2. healthy control group * controls aged 18 years old and above. exclusion criteria: * contraindications to mri, such as cardiac pacemaker, claustrophobia, pregnancy, metallic implants not suitable for mri scan.

Keywords: magnetic resonance imaging quantitative imaging spin-lock
efficacy and safety of jmt101 in patients with advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: this study is a phase i, open label, multi-center study of to evaluate the safety and efficacy of jmt101 in patients with advanced solid tumor.

the objective of the trial is to evaluate the safety and efficacy of jmt101 in patients with advanced solid tumor. this study consists of two parts (stage i and stage ii). stage i was a dose escalation study, and stage ii was a dose expansion study.

Eligibility criteria:
inclusion criteria: * monotherapy: pathologically or cytologically confirmed, advanced solid tumor, harboring ras wild type; combined with chemotherapy: pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring ras and braf v600e wild type. * at least 1 measurable lesion according to recist 1.1; * ecog score 0 or 1; * stable for more than 14 days of brain metastasis or spinal cord compression. exclusion criteria: * receipt of any egfr inhibitors within 5 months prior to the first dose of study treatment. * the second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment. * known hypersensitivity to any ingredient of jmt101 or their excipients; * major surgery within prior 4 weeks of first treatment. * receiving an investigational product in another clinical study within 4 weeks; * history of serious systemic diseases; * pregnancy or lactating wo